MOUNTAINEER 188318414Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034157405), received between Nov 21, 2014 and Nov 15, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT A CERVICAL-THORACIC POSTERIOR FUSION (C4-T2 EXCLUDING C7) FOR OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENT (OPLL). ON (B)(6) 2021 THE PATIENT WAS DIAGNOSED WITH ADJACENT SEGMENT DISEASE (ASD) WHICH REQUIRED DECOMPRESSION FUSION BETWEEN T2 AND T3. ALL IMPLANTS FUSED IN 2011 HAD NO DEFECT SO THE FUSION WILL BE EXTENDED. THE REVISION OF C7, T3 (OR UP TO T4) WAS PLANNED FOR (B)(6) 2021. THIS REPORT IS FOR ONE (1) MINI POLYAXIAL BONE SCREW 3.5 X 4 X 14MM. THIS IS REPORT 5 OF 11 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12814470 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT A CERVICAL-THORACIC POSTERIOR FUSION (C4-T2 EXCLUDING C7) FOR OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENT (OPLL). ON (B)(6) 2021 THE PATIENT WAS DIAGNOSED WITH ADJACENT SEGMENT DISEASE (ASD) WHICH REQUIRED DECOMPRESSION FUSION BETWEEN T2 AND T3. ALL IMPLANTS FUSED IN 2011 HAD NO DEFECT SO THE FUSION WILL BE EXTENDED. THE REVISION OF C7, T3 (OR UP TO T4) WAS PLANNED FOR (B)(6) 2021. THIS REPORT IS FOR ONE (1) MINI POLYAXIAL BONE SCREW 3.5 X 4 X 14MM. THIS IS REPORT 3 OF 11 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12814288 ↗
• MalfunctionNov 21, 2014Break; Material Deformation

  PRE-OPERATIVE DIAGNOSIS: SEVERE CERVICAL SPINAL STENOSIS WITH SIGNS OF MYELOPATHY LEVEL(S) OPERATED C3-C6; LEVEL(S) INSTRUMENTED C3-C6. SET SCREWS WERE USED TO LOCK RODS INTO MOUNTAINEER FAVORED ANGLE SCREWS AND TALL INNER SCREWS WERE INSERTED INTO THE CROSSLINK USING THE TORQUE LIMITING HANDLE. THE SURGEON PLACED CROSS CONNECTORS OVER THE INNER SCREWS AND THEN TRIED TO PLACE THE LOCKING NUT OVER THE LINK WITH A TORQUE LIMITING NUT DRIVER. AS HE WAS TIGHTENING, A POP WAS HEARD AND THE SURGEON STATED THAT THE SCREW BROKE. HE TOOK OUT THE INSTRUMENTATION AND REPLACED THE SCREW. THIS WAS DONE SEVERAL TIMES WITH THE SAME RESULT. IT WAS REPORTED THAT EITHER THE MOUNTAINEER H/H CROSS CONNECTOR INNER SCREW BROKE OR THE THREADS ON THE PEDICLE SCREW BROKE. THREADS OF CROSS CONNECTOR INNER SCREWS WERE REPORTED TO BE TORN AND MISSING AND THREADS OF FAVORED ANGLE SCREW TULIP HEADS (IE. SCREW HEADS) WERE TORN. THE DIFFICULTY RESULTED IN A NINETY MINUTE DELAY TO THE PROCEDURE. EIGHT MFG. MEDWATC REPORTS ARE BEING FILED FOR THE MOUNTAINEER FAVORED ANGLE SCREWS AND CROSS CONNECTOR INNER SCREWS THAT WERE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 4270584 ↗